FDA recall, , Moderate risk
Philips Azurion Systems
Philips Azurion systems may have table movements impacted due to mechanical wear of the Float Tabletop control.
Summary by Recall Canary from the FDA notice
What happened
Philips Medical Systems Nederland B.V. of Best, Netherlands, recalled 5,537 Philips Azurion systems not configured with an optional auxiliary pan handle, including models such as Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, and Azurion 7 B20. The recall was prompted by a potential safety issue where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
The recall began on April 28, 2026, and was added to the FDA's Enforcement Report on May 21, 2026.
Distribution was nationwide and international, including Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, Côte d'Ivoire, El Salvador, Estonia, Greece, Honduras, Hong Kong, Iceland, Indonesia, Iraq, Japan, Kyrgyzstan, Malaysia, Malta, Moldova, Nepal, New Zealand, Philippines, Qatar, Singapore, South Africa, Sri Lanka, Syrian Arab Republic, Tanzania, Turkmenistan, Vietnam, Yemen.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number and UDI-DI are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Azurion 3 M12
- Model number
- 722063
- 722229
- UDI-DI
- 00884838085275
- 00884838116726
- 00884838085282
- 00884838099210
- 00884838116733
- 00884838103276
- 00884838099227
- 00884838116740
- 00884838099234
- 0884838099234
- 00884838116757
- 00884838110564
- 00884838085350
- 00884838099265
- 00884838116788
- 00884838085367
- 00884838099272
- 00884838116801
- 00884838085251
- 0088483808525
- 00884838099241
- 00884838116764
- 00884838085268
- 00884838099258
- 84838099258
- 6600558517
- 00884838116771
- 00884838110571
Azurion 3 M15
- Model number
- 722222
- 722064
- 722280
- 722230
Azurion 5 M12
- Model number
- 722227
- 722231
Azurion 5 M20
- Model number
- 722228
- 722232
- 722281
Azurion 7 B12
- Model number
- 722067
- 722225
- 722235
Azurion 7 B20
- Model number
- 722068
- 722226
- 722236
Azurion 7 M12
- Model number
- 722078
- 722223
- 722233
Azurion 7 M20
- Model number
- 722079
- 722224
- 722234
- 722282
Recall details
- Company began the recall
- Sold in
Nationwide distribution. International distribution to Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, C¿te D'Ivoire, El Salvador, Estonia, Greece, Honduras, Hong Kong, Iceland, Indonesia, Iraq, Japan, Kyrgyzstan, Malaysia, Malta, Moldova, Nepal, New Zealand, Philippines, Qatar, Singapore, South Africa, Sri Lanka, Syrian Arab Republic, Tanzania, Turkmenistan, Vietnam, Yemen
- Company
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, Netherlands
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98812
- Recall number
- Z-2225-2026
- Quantity recalled
- 5,537 units
All recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated